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Completed

NCT Number: NCT05265260

Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults

The aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a Nucleus cochlear implant.

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Key information

Conditions

Sensorineural Hearing Loss, Bilateral Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pierre-Paul Riquet, ORL, otoneurologie et ORL pédiatrique

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subjects, 18 years or older
  • Subjects unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.
  • Subjects who have been implanted between January 2016 and December 2021.
  • Subjects have received a Nucleus CI: CI512, CI522 or CI532 cochlear implants with non-rotating magnet, or CI600 series equivalent CI612, CI622 and CI632 with rotating magnet and external sound processors CP900 or CP1000 behind-the-ear, or Kanso or Kanso 2 off-the-ear types.
  • Subjects who are fluent in French (language used in the questionnaire and speech tests)
  • Subjects who are not opposed to participating in the study
  • Subjects for who the medical record data is available throughout the defined data search period.

Exclusion criteria

  • Subjects with single-sided deafness (SSD).
  • Subjects who are not affiliated to the French Social Security.
  • Subjects who are under legal protection.

Treatment and study plan

Primary outcomes

  1. Score of the French MBAA2 Sentence Recognition Test in Quiet

    Time frame: 1 month post activation

    Participants are classified in good or poor performer based on the score of the French MBAA2 sentence recognition test. A good performer has a score of ≥90/100 correct sentence. A bad performer has a score of <90/100 correct sentence.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • EVAMED

Registry information

Official study title

Barriers to Early Progress in Cochlear Implant Outcomes: a Non-interventional Feasibility Study

Acronym: PROGRESS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2022
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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